[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623687":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":31,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":31,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":31,"enrollmentInfo":67,"targetDuration":31,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":83,"whyStopped":31,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":31},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","ACTIVE_COMPARATOR","Participants randomized to the standard-of-care arm will receive STI testing via a routine, laboratory-based assay for C. trachomatis and N. gonorrhoeae.",[13],"Diagnostic Test: Laboratory-based chlamydia and gonorrhea NAAT",{"label":15,"type":16,"description":17,"interventionNames":18},"Point-of-care Testing","EXPERIMENTAL","Participants randomized to this arm will receive a point-of-care testing in addition to standard, laboratory-based testing for C. trachomatis and N. gonorrhoeae.",[19,13],"Diagnostic Test: Point-of-care assay for chlamydia and gonorrhea",{"label":21,"type":6,"description":22,"interventionNames":23},"CRISPR-based Assay Assessment","Participants in this arm will have collection of additional samples for testing via a research-only, novel CRISPR-based assay for STIs and antimicrobial resistance.",[24],"Diagnostic Test: CRISPR-based assay",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIAGNOSTIC_TEST","Point-of-care assay for chlamydia and gonorrhea","This intervention consists of use of Cobas® Liat CT\u002FNG Assay (Roche, United States).",[15],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Laboratory-based chlamydia and gonorrhea NAAT","This intervention consists of routine, laboratory-based diagnostic testing for chlamydia and gonorrhea via nucleic acid amplification.",[15,9],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"CRISPR-based assay","This is a novel assay using CRISPR technology to assess for STIs and antimicrobial resistance.",[21],[41,46],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Kevin L Ard, MD","CONTACT","617-724-9441","kard@mgh.harvard.edu",{"name":47,"role":43,"phone":31,"phoneExt":31,"email":48},"Lao-Tzu Allan-Blitz, MD","lallanblitz@mednet.ucla.edu",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Kevin L, Ard","Director, Sexual Health Clinic",[54],{"name":55,"class":56},"Roche Diagnostic Ltd.","INDUSTRY","100623687","outcomes-from-point-of-care-sexually-transmitted-infection-sti-testing-in-an-urban-sexual-health-clinic-a-randomized-trial-100623687",false,"NCT07399873","Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial","Outcomes From Point-of-Care STI Testing in an Urban Sexual Health Clinic: A Randomized Trial","Inclusion Criteria:\n\n* At least 18 years of age\n* Willing and able to provide informed consent\n* Asymptomatic at the urogenital site\n* Being screened for urogenital C. trachomatis and\u002For N. gonorrhoeae as part of routine clinical care\n\nExclusion Criteria:\n\n* Indication for antimicrobial therapy for C. trachomatis or N. gonorrhoeae at the time of the visit, regardless of test results",true,"ALL","18 Years",{"count":68,"type":69},400,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to learn about the impact of a point-of-care test for gonorrhea and chlamydia in people without symptoms who are seeking sexually transmitted infection testing. The main questions it aims to answer are:\n\nDoes the point of care test reduce the time to antibiotic treatment? Does the point of care test increase the number of people who have completed treatment by day 7?\n\nResearchers will compare the point-of-care test to a standard laboratory-based test for gonorrhea and chlamydia.\n\nParticipants will be asked to provide a urine sample or vaginal swab for testing. They will also complete surveys about their experiences with the testing.",[75,76],"Neisseria Gonorrhoeae Infection","Chlamydia Trachomatis Infection",[78,79,80,81,82],"gonorrhea","chlamydia","sexually transmitted infection","STI","point-of-care testing","NOT_YET_RECRUITING","2026-04-16",{"date":86,"type":87},"2026-04-17","ACTUAL",{"date":89,"type":69},"2026-06",{"date":91,"type":69},"2027-02",{"name":5,"class":6}]